Recall Z-3147-2026— Bayer Medical Care, Inc.

Name: FDA recall Z-3147-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Class II · Ongoing

Class II FDA medical device recall by Bayer Medical Care, Inc., initiated 2026-07-31. It names one FDA 510(k) clearance: K182273. Product: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;. Reason: Some devices may not have been properly sterilized due to a manufacturing sterilization issue..

Recalling firm: Bayer Medical Care, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-31
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K182273 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTBayer Medical Care, Inc.·cleared 2018-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Reason for recall

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.